, /PRNewswire/ -- ("Adcentrx"), a biotechnology company revolutionizing Antibody-Drug Conjugate (ADC) therapeutics for cancer and other life-threatening diseases, announced today that China National Medical Products Administration (NMPA) has cleared Adcentrx's Investigational New Drug (IND) application for ADRX-0706 which enables the company to include -based clinical centers in the ongoing Phase 1a/ study for the treatment of select advanced solid tumors. ADRX-0706 is an ADC comprised of a novel fully human IgG1 antibody targeting human Nectin-4 linked to a proprietary tubulin inhibitor payload, AP052, through Adcentrx's innovative i-ConjugationTM technology using a cleavable linker and stable conjugation chemistry. This novel platform technology enables a highly stable ADC with a drug-antibody ratio of eight (DAR 8) with a substantially expanded therapeutic window as demonstrated in preclinical studies.
Nectin-4 is a validated target for ADCs with high expression in multiple solid tumors and limited expression in normal tissues. It plays a crucial role in tumor progression and has been associated with poor prognosis and resistance to conventional therapies. "NMPA's clearance of the ADRX-0706 IND is an important milestone for Adcentrx," said , Ph.
D., Founder and Chief Executive Officer of Adcentrx. "We now have the ability to recruit patients in both the U.
S. and to generate valuable data in different patient populations, and the data will enable us to further explore ADRX-0.
